Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Phase 4
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Inclusion Criteria:
- underwent macroscopically curative resection;
- immunohistochemically confirmed KIT (CD117)-positive tumors;
- judged as being high-risk according to the criteria for risk classification
Exclusion Criteria:
- synchronous double cancer or metachronous double cancer with a disease-free period of
≤5 years;
- received therapy with Imatinib Mesylate prior to study entry;
- cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
Other protocol-defined inclusion / exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CSTI571BJP07
NCT ID:
NCT00171977
Start Date:
July 2004
Completion Date:
Related Keywords:
- Gastrointestinal Stromal Tumors
- GIST
- Imatinib
- Postoperative Adjuvant
- Gastrointestinal Stromal Tumors
Name | Location |
|---|
